European Plant Problems Stalls Nabriva’s Antibiotic Approval

May 7, 2019

Problems in one of Nabriva’s subcontracting plants have stalled the FDA’s review of the company’s proposed IV antibiotic Contepo.

The FDA sent a complete response letter to Nabriva saying that “manufacturing deficiencies” in the European plant meant the agency couldn’t approve Contepo (fosfomycin) just yet, Nabriva CEO Ted Schroeder said in a conference call on Wednesday. “We expect that this will be a solvable set of issues,” he said.

Schroeder said the company is exploring back-up supply chains for Contepo and it will request a meeting with regulators and the drug subcontractor as soon as possible.

Contepo is one of three drugs in Nabriva’s pipeline. Another antibiotic, lefamulin, is due for a PDUFA response for pneumonia in August. It has undergone a Phase II trial for skin infections and is currently in a Phase I trial for pediatric patients.

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